Cold atmospheric plasma plus endovascular treatment for diabetic foot ulcers with blocked lower‑leg arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults with diabetes who have chronic foot ulcers and documented infrapopliteal arterial stenosis or occlusion who undergo successful infrapopliteal balloon angioplasty. After confirming arterial patency by intraoperative angiography, participants receive either cold atmospheric plasma treatment to the ulcer or a sham procedure in addition to standard wound care. The goal is to determine whether the local application of cold atmospheric plasma improves microvascular perfusion and accelerates wound healing beyond revascularization alone. Outcomes will include wound healing measures and safety endpoints over a defined follow‑up period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18-80 years, with a diagnosis of type 1 or type 2 diabetes and diabetic foot ulcer; glycated hemoglobin (HbA1c) ≤ 10%.
* Presence of at least one chronic foot ulcer persisting for at least three weeks, with no signs of healing after standard-of-care treatment based on current clinical guidelines. The ulcer must be classified as Wagner-Armstrong grade 1D or 2D (Wagner: superficial ulcer \[grade 1\] or ulcer extending to tendon \[grade 2\]; Armstrong: presence of both ischaemia and infection \[stage D\]).
* Documented infrapopliteal arterial stenosis or occlusion by vascular ultrasound and/or CT angiography (CTA), meeting indications for revascularization. All enrolled patients must have received successful infrapopliteal balloon angioplasty, with intraoperative angiography confirming target artery patency.
* Provision of written informed consent.

Exclusion Criteria:

* Concurrent treatment of the wound with local vacuum therapy or maggot therapy.
* Undergoing dialysis.
* Use of local active antibiotics.
* Treatment with platelet-rich fibrin.
* Women of childbearing potential without effective contraception, or women who are actively breastfeeding.
* Presence of other severe organ dysfunction, with an expected survival of less than six months.
* Participation in another clinical trial within the past three months or currently enrolled in another clinical trial.

Where it's running

• Ansteel General Hospital
  Anshan, Liaoning, China Recruiting

Study contacts

• Principal investigator: Lin Tao, MM — Shenyang Medical College
• Study coordinator: Yun-En Liu, MD
• Email: lye9901@163.com
• Phone: 86-24-62215130

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.